Drug delivery system comprising a non-steroidal anti-inflammatory (nsaid) and a progestogenic compound and methods for manufacturing

Abstract

The invention is describing an intrauterine delivery system comprising non-steroidal anti-inflammatory (NSAID) and a progestogenic compound, containing anti-inflammatory active compound in the frame material and that the progestogenic compound is contained in a silicon based reservoir attached to the frame, wherein the frame consist of a thermoplastic material. A further object of the invention is to fabricate drug-containing T-intrauterine systems (I US) with the drug incorporated within the entire backbone of the medical device by using 3D printing technique, based on fused deposition modelling (FDM™). Indomethacin was used to prepare drug-loaded poly-caprolactone (PCL)-based filaments with different drug contents 5-40 wt %, namely 5%, 15% and 30% wt %: of Indomethacin.

1 . An intrauterine delivery system comprising non-steroidal anti-inflammatory drug (NSAID) and a progestogenic compound, characterized in that the NSAID is contained in the frame material and that the progestogenic compound is contained in a silicon-based reservoir attached to the frame, wherein the frame consists of a thermoplastic material. 
     
     
         2 . Intrauterine System according to  claim 1 , wherein the NSAID is indomethacin. 
     
     
         3 . Intrauterine System according to  claim 1 , wherein the progestogenic compound is levonorgestrel. 
     
     
         4 . LAB Intrauterine System according to  claim 1 , wherein the thermoplastic material is polycaprolactone or ethylene-vinyl-acetate or a mixture thereof. 
     
     
         5 . Intrauterine System according to  claim 1 , wherein the thermoplastic material is ethylene-vinyl-acetate. 
     
     
         6 . A method for manufacturing a frame as a component of an intrauterine delivery system according to  claim 1 , wherein a mixture of the thermoplastic material and the NSAID is treated under the conditions of 3D printing. 
     
     
         7 . A method of  claim 6 , wherein the intrauterine delivery system for the controlled release of progestogen or a drug having a progestogenic activity over a prolonged period of time and at a level required for contraception, and the system comprises a body construction and at least one reservoir comprising a core and optionally a membrane encasing the core, the core and membrane essentially consisting of a same or different polymer composition, characterized in that said intrauterine delivery system comprises levonorgestrel as a progestogen or a drug having progestorgenic activity. 
     
     
         8 . A method of  claim 6 , wherein the thermoplastic material is polycaprolactone or ethylene-vinyl-acetate or a mixture thereof. 
     
     
         9 . A method of  claim 6 , wherein the thermoplastics material is ethylene-vinyl-acetate. 
     
     
         10 . A method of  claim 6 , wherein the NSAID indomethacin. 
     
     
         11 . A method according to  claim 10 , wherein the indomethacin is in the range of 5-40 wt-%. 
     
     
         12 . A method according to  claim 11 , wherein the indomethacin is in the amount of 5 or 15 or 30 wt-%. 
     
     
         13 . A method according to  claim 10 , wherein the indomethacin is amorphous or α-indomethacin. 
     
     
         14 . A device constructed according to  claim 6 , wherein the intrauterine delivery system comprises a body construction and at least one reservoir comprising a core and optionally a membrane encasing the core, the core and membrane essentially consisting of a same or different polymer composition, comprises levonorgestrel as a progestogen or a drug having progestogenic activity.